# US 7,744,651 B2 · Compositions and methods for treating intervertebral discs with collagen-based materials

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- Number: US 7,744,651 B2
- Document ID: US7744651B2
- Status: Granted
- Kind: B2
- Application number: 11/030,705
- Filed: 2005-01-06
- Published: 2005-06-02
- Granted: 2010-06-29
- Earliest claimed: 2002-09-18
- Assignees: Warsaw Orthopedic, Inc.
- Inventors: Hai H. Trieu; Michael C. Sherman
- Web page: https://patentgrep.com/patent/US7744651B2

## CPC

- A61L 27/3834: {Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells}
- A61B 17/7061: {for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange (intraosseous injection devices A61B17/3472)}
- A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- A61L 27/24: Collagen
- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A61L 27/3658: {Intervertebral discs (mechanical aspects and structures of intervertebral discs A61F2/442)}
- A61L 27/3856: {Intervertebral discs (mechanical aspects and structures of intervertebral discs A61F2/442)}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/18: Materials at least partially X-ray or laser opaque
- A61B 17/562: {Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain}
- A61B 17/7064: {Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61F 2/08: Muscles; Tendons; Ligaments
- A61F 2/4405: {for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes (devices implanted between spinous or transverse processes A61B17/7062)}
- A61F 2002/30075: {swellable, e.g. when wetted}
- A61F 2002/3008: {radio-opaque, e.g. radio-opaque markers}
- A61F 2002/30224: {cylindrical}
- A61F 2002/30588: {filled with solid particles}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/4077: {Distal or diaphyseal parts of shafts}
- A61F 2002/444: {for replacing the nucleus pulposus}
- A61F 2002/445: {Intervertebral disc tissue harvest sites}
- A61F 2002/4635: {using minimally invasive surgery}
- A61F 2210/0061: swellable
- A61F 2230/0069: cylindrical
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61L 2300/402: Anaestetics, analgesics, e.g. lidocaine
- A61L 2300/406: Antibiotics
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/414: Growth factors
- A61L 2300/44: Radioisotopes, radionuclides
- A61L 2300/64: Animal cells
- A61L 2430/24: for joint reconstruction
- A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A method of augmenting an intervertebral disc nucleus by injecting or otherwise adding to a disc nucleus a plurality of particles of natural, collagen-rich tissue. The mean particle size of the pieces of natural, collagen-rich tissue may be between 0.25 mm and 1.0 mm. The particles may be dehydrated before implantation, and rehydrated after implantation, or they may be implanted in a “wet” state—such as a slurry or gel. Radiocontrast materials may be included to enhance imaging of the injected material. Other additives may include analgesics, antibiotics, proteoglycans, growth factors, stem cells, and/or other cells effective to promote healing and/or proper disc function.

## Claims

### Claim 1

A method of augmenting an intervertebral disc nucleus, said method comprising surgically adding to an intervertebral disc nucleus contained within a disc annulus an injectable material including:
a) a plurality of particles of natural tissue selected from the group consisting of intervertebral disc, fascia, ligament, tendon, skin, and other connective tissue, wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.05 mm and 5.0 mm; and
b) a biologically active substance effective to promote healing, repair, regeneration and/or restoration of the disc, and/or to facilitate proper disc function.

### Claim 2 (depends on 1)

The method of claim 1 wherein said biologically active substance is a growth factor.

### Claim 3 (depends on 2)

The method of claim 2 wherein said growth factor comprises one or more members selected from, the group consisting of bone morphogenetic protein, transforming growth factor-β (TGF-β), insulin-like growth factor, platelet-derived growth factor, fibroblast growth factor, or other growth factors having the ability to repair the endplates and/or the annulus fibrosis of an intervertebral disc.

### Claim 4 (depends on 1)

The method of claim 1 wherein said biologically active substance comprises one or more members selected from the group consisting of antibiotics, analgesics, anti-inflammatories, and steroids.

### Claim 5 (depends on 1)

The method of claim 1 wherein said biologically active substance comprises stem cells.

### Claim 6 (depends on 1)

The method of claim 1 wherein said method further includes adding a radiographic contrast media to the intervertebral disc nucleus.

### Claim 7 (depends on 1)

The method of claim 1 wherein said method further includes adding a polysaccharide to the intervertebral disc nucleus.

### Claim 8 (depends on 7)

The method of claim 7 wherein said polysaccharide is a, proteoglycan and/or a hyaluronic acid.

### Claim 9 (depends on 1)

The method of claim 1 wherein said method further includes adding a cross-linking agent to the intervertebral disc nucleus, to promote crosslinking of collagen molecules.

### Claim 10 (depends on 1)

The method of claim 1 wherein said biologically active substance is effective for treating one or more medical conditions selected from the group consisting of degenerative disc disease, spinal arthritis, spinal infection, spinal, tumor, and osteoporosis.

### Claim 11 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.25 mm and 1.0 mm.

### Claim 12 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue has a mean particle size of between 0.25 mm and 0.5 mm.

### Claim 13 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue has a. mean particle size of between 0.5 mm and 1.0 mm.

### Claim 14 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus in a dehydrated state.

### Claim 15 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus in a non-dehydrated state.

### Claim 16 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus as a gel.

### Claim 17 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue are added to the disc nucleus as a suspension.

### Claim 18 (depends on 1)

The method of claim 1 wherein said natural, collagen-rich tissue is an allograft tissue.

### Claim 19 (depends on 1)

The method of claim 1 wherein said, natural, collagen-rich tissue is an autograft tissue.

### Claim 20 (depends on 1)

The method of claim 1 wherein said natural, collagen-rich tissue is a xenograft tissue.

### Claim 21 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance are surgically added simultaneously.

### Claim 22 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance, are surgically added sequentially.

### Claim 23

The method of claim, 1 wherein said, plurality of particles of natural, collagen-rich tissue, and said biologically active substance, are surgically added by needle injection.

### Claim 24 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance, are surgically added by catheter infusion.

### Claim 25 (depends on 1)

The method of claim 1 wherein said plurality of particles of natural, collagen-rich tissue, and said biologically active substance, are surgically added by extrusion.